The Role of Analytics in Reproducibility and Regulatory Approval of Cell and Gene Therapies

The potential of the cell and gene therapy field is prohibited by the current costs and logistics of harvesting a patient’s cells, processing them at a centralised location and delivering them back to the patient. To create change, both technology and manufacturing-model innovation are required. Analytics, real-time monitoring, and data are going to be essential in reducing CoGs and improving access to and commercial viability of therapies.

However, there is a serious lack of purpose-built bioprocessing technologies for cell and gene therapy manufacturing. Those that are available are mostly based on legacy MAbs technologies that have not changed in decades. When it comes to real-time, remote monitoring sensors and analytics, there is very little available to the cell and gene therapy industry.

Analytics deserves its time in the spotlight for a few reasons. First, is a recent string of highly publicized, late-stage review issues from the FDA that were mostly due to CMC-related causes. Iovance and Sarepta’s cases were linked to potency assays; could these have been avoided with the effective application of analytics to better characterise the product through critical quality attributes (CQAs)?

So, what’s preventing developers from designing mechanistically relevant assays?

This report examines the above question, focusing on:

  • The identification and measurement of appropriate CQAs
  • The value of fit-for-purpose analytics technologies
  • What the future of CGT manufacturing analytics should look like

This report has been produced in partnership with Bio-Techne